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We are in an unprecedented time in neurotherapeutics. Medicines that address the causative disease biology underlying central nervous system
In a fireside chat at the American Society of Gene & Cell Therapy conference, CBER Director Peter Marks spoke with Takeda’s Kristin Van Goor about how the regulator is approaching the exploding gene therapy space.
While Teva missed Wall Street expectations in the first quarter of 2024, it reported Wednesday a 5% increase in Q1 revenues while reporting that the company’s schizophrenia candidate scored a late-stage trial victory
Regeneron Pharmaceuticals on Wednesday revealed that its investigational gene therapy DB-OTO restored hearing in two young children, according to an oral presentation at the American Society of Gene & Cell Therapy annual meeting.
Amylyx’s recent decision to withdraw its ALS drug Relyvrio from the market highlights an important business decision for companies: when to continue marketing or investigating a drug that has failed a pivotal or confirmatory study.
AstraZeneca announced that it will voluntarily pull Vaxzevria from the global market amid a sharp decline in demand and following the company’s recent admission that its vaccine is linked with a rare side effect.
As interest in psychedelic therapies ramp up, Lykos Therapeutics will go in front of the FDA’s Psychopharmacologic Drugs Advisory Committee on June 4 to present its investigational treatment for post-traumatic stress disorder.
Pfizer’s investigational Duchenne muscular dystrophy gene therapy fordadistrogene movaparvovec has been hit with another patient death, forcing the pharma to pause dosing in its Phase III study.
As Sarepta Therapeutics moves closer to full approval and an expanded label for its gene therapy, some experts push back on clinical efficacy and cost while others note the hope it provides patients with Duchenne muscular dystrophy.
The biotech touted its prime editing technology at ASGCT on Tuesday after receiving FDA clearance last week for a clinical study of a drug candidate based on the platform.
Tuesday afternoon’s session was standing room only as representatives from various biopharma companies presented on their work to improve the efficiency and quality of AAV production.
AAVs and accelerated approval are just two of the topics being discussed at ASGCT. Meanwhile, the race between Vertex and bluebird bio’s gene therapies Casgevy and Lyfgenia is heating up.
With appeals and additional cases still pending, it remains to be seen if any of the arguments being brought by biopharma companies against the U.S. government will hold up in court.
The FDA is looking at four decision deadlines in the coming three weeks, including two for a CAR-T therapy and another for a hepatitis B vaccine.
The newest company by the life sciences venture capital firm, Prologue Medicines will search through the vast viral proteome to identify proteins with therapeutic potential.
With a total revenue of nearly $2.7 billion, Vertex exceeded analyst estimates in the first quarter, bolstered by strong uptake of its cystic fibrosis products.
ADC Therapeutics is positioning Zynlonta for a label expansion with new Phase II data showing that the treatment can elicit high rates of complete response in patients with relapsed or refractory marginal zone lymphoma.
In a joint conference event on Monday, cell therapy pioneer Carl June revealed unpublished results showing that in around 1,500 patients treated with CAR-T therapies, no cases of secondary malignancy could be definitively linked to the treatment.
BioSpace’s third report on diversity, equity, inclusion and belonging in life sciences examines dramatic shifts in attitude around diversity initiatives.
BioSpace will be in attendance at the American Society of Gene & Cell Therapy’s 27th annual meeting, along with thousands of others. Stay with us for updates throughout the week.